Efficacy of Intermittent Screening and Treatment or Intermittent Preventive Treatment (IPT) With Dihydroartemisinin-Piperaquine, Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals in the second and third trimesters of pregnancy irrespective of the presence of malaria parasitemia, is currently recommended for HIV-negative women in all areas with stable moderate to high transmission of malaria. Due to increasing resistance to SP, it is no longer used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for IPTp, as well as to explore the strategy of intermittent screening and treatment in pregnancy (ISTp) with DP. This strategy uses increased screening at time of focused antenatal care (FANC) with treatment of women who screen positive.

The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in an area with decreasing malaria transmission and high levels of SP resistance in Kenya.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kenya Medical Research Institute
• Collaborators: Centers for Disease Control and Prevention; Liverpool School of Tropical Medicine; London School of Hygiene and Tropical Medicine
• Treatments: Artemisinins; Dihydroartemisinin; Fanasil, pyrimethamine drug combination; Piperaquine; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

1. Viable pregnancy assessed by Doppler

2. Gestational age 16 to 32 weeks (inclusive) by fundal height

3. No history of IPTp use during this pregnancy

4. Willing to participate and complete the study schedule

5. Willing to sign or thumb print informed consent

6. Resident of study area and intending to stay in the area for the duration of the follow-up

7. Willing to deliver in the labor ward of the study clinic or hospital

8. HIV negative at enrolment

Exclusion Criteria:

1. HIV positive or unknown

2. Residence outside study area or planning to move out in the 12 months following enrolment

3. High risk pregnancy, including any pre-existing illness likely to cause complication of pregnancy (hypertension, diabetes, asthma, epilepsy, renal disease, liver disease, fistula repair, leg or spine deformity)

4. Severe anemia requiring blood transfusion (Hb ≤ 7.0 g/dL) at enrolment

5. Known allergy or previous adverse reaction to any of the study drugs

6. Unable to give informed consent (for example due to mental disability)

7. Previous inclusion in the same study

8. Gestational age >32 weeks

9. Previous IPTp during the current pregnancy

10. Participating in other malaria intervention studies

11. Known or suspected cardiac disease

12. Patients taking drugs in any of the following classes: antiarrhythmic agents, neuroleptics, macrolides, and certain antimalarial drugs such as mefloquine, chloroquine, halofantrine and lumefantrine.